FDA advisers question seasonal updates

of U.S. Food and Drug AdministrationIndependent Advisory Board of question arose about the need to Update “Regularly” Regarding the new coronavirus vaccine, he pointed out that it is unclear whether the virus is seasonal like influenza.

advisor on thursday voted unanimously Fall’s new jabs should be monovalent, meaning they’re designed against a type of novel coronavirus and target either: Omicron XBB strain. they are now dominant variant Nationwide.

but original poll question Included language on whether the committee recommends “routine renewal” of COVID-19 vaccinations.

Dr. Peter Marks, director of the FDA’s Vaccines Division, asked the committee chair to remove the wording of the question after several advisers expressed concerns.

Dr. Arthur Rheingold, professor of epidemiology at the University of California, Berkeley, said: “It seems like we’re in agreement that we literally need to update on a regular basis, but I don’t think it’s clear.” said.

The commission’s concerns indicate that despite the decline in the number of infections and deaths nationwide, there remains uncertainty about what the COVID-19 pandemic will look like in the years to come. ing.

This concern is also a recent backlash against the FDA. proposed shift Earlier this year, we transitioned to annual new coronavirus vaccinations. This is a simplified approach to vaccination that will renew the jab yearly. This is similar to how the United States introduces new flu vaccines each fall and winter, when infections spike.

But some advisers cautioned against calling the new coronavirus a seasonal one, like the flu.

“We still don’t know for sure if this is a seasonal virus,” said Henry Bernstein, a pediatrician at Cohen Children’s Medical Center.

Mark Sawyer, Ph.D., professor of clinical pediatrics at the University of California, San Diego, said describing the novel coronavirus as “seasonal” will ultimately lead the public to “when, where and how often to get vaccinated.” He added that it can be confusing.

“I join the choir here. I think using the word season is equally problematic,” he said. Dr. Sawyer. “We are tying the campaign to the flu vaccine. We understand that it may be convenient and most efficient to get the vaccines together, but it is only a few years old and we are not aware of the COVID-19 season. I really don’t know how it will turn out.”

Unlike influenza, the spread of COVID-19 is often volatile. The virus is constantly mutating into new variants and has yet to settle into predictable seasonal patterns.

In response to advisers, FDA’s Marks emphasized that the new coronavirus vaccine will likely require a new update “at some point.”

“This will not be the final formulation of this vaccine forever,” he said.

The move to an annual updated COVID-19 vaccine, endorsed by former White House health officials Dr. Ashish Jah and Dr. Anthony Fauci among others, will see the country adopt a similar approach to flu vaccinations. I think you will benefit from it.

Each year, researchers assess the strains of influenza that are circulating, estimate which strains will be most prevalent in the fall and winter, and then update the jab.

“People go get the flu vaccine every year if they think it’s part of their routine treatment. I’m not thinking if it’s the flu shot or the 29th flu shot, I think it’s the annual flu shot,” Jah said in an interview Wednesday. interview on PBS Newshour.

“For most people, if you think of this as a yearly COVID-19 vaccine, you’re getting it when you get your flu shot. I think that’s going to make an important difference,” he continued. .

Recent polls show that the public is open to the idea.

More than half of nearly 1,200 U.S. adult respondents said they would be more likely to get the COVID-19 vaccine annually if offered, similar to their annual flu shot, according to April survey results. . investigation According to health policy group KFF. This includes 32% who believe they are ‘very likely’ to do so.

It’s unclear how many Americans will roll up their sleeves for the latest photos this fall and winter.

Uptake of the original novel coronavirus strain and the latest bivalent boosters targeting Omicron BA.4 and BA.5 has slowed.

just about 17% of the US population —about 56 million people—have received Pfizer and modern Additional boosters have been added since it was approved in September, according to the Centers for Disease Control and Prevention.

Pfizer, a major maker of the new coronavirus vaccine told CNBC Last month, it announced that the annual schedule for COVID-19 could encourage more people to get vaccinated each year.

Pfizer’s chief scientific officer, Dr. Michael Dorsten, said the change comes at a time when people see COVID-19 vaccination as just a “natural part” of protecting their health. Said it might help.

Pfizer is already preparing to move to an annual schedule by developing a “next-generation” version of its vaccine. The aim is to expand and extend the protection people get from the virus over the years.